Head Of Product Quality Manufacturing And Testing

argenx

Onsite
10+ years quality assurance experience
Biopharmaceutical manufacturing operations knowledge
Gmp regulatory compliance expertise
This role sets the strategic vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery for autoimmune patients

Job Summary

  • This role sets the strategic vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery for autoimmune patients.
  • The successful candidate will serve as the GMP strategic authority, ensuring sustained compliance and inspection readiness across global networks and third-party partners.
  • The position requires leading a high-performing organization that fosters accountability, engagement, and succession readiness while driving a culture of continuous improvement.

Matching Summary

This role sets the strategic vision for Manufacturing and Testing Product Quality to enable reliable, compliant, and efficient product delivery for autoimmune patients.

Skills & Requirements

Must-have

  • 10+ years quality assurance experience
  • Biopharmaceutical manufacturing operations knowledge
  • GMP regulatory compliance expertise
  • FDA EU PMDA inspection management
  • Third-party vendor network governance

Nice-to-have

  • Strong collaborative leadership skills
  • Experience in fast-paced biotech environment
  • Excellent scientific writing abilities
  • Data-driven decision-making capabilities

Key Requirements

  • 10+ years QA experience in biopharmaceuticals
  • Knowledge of analytical techniques
  • Extensive audit and inspection preparation experience
  • In-depth knowledge of ICH Guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter